Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Contact dermatitis to lauryl pyridinium chloride and benzoxonium chloride
Author:
DERK P. BRUYNZEEL, ANTON C. DE GROOT AND J. WILLEM WEYLAND
Year:
1987
Bibliographic source:
Contact Dermatitis 1987• 17: 41-60

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Patch tests with the European standard series (ICDRG)
Principles of method if other than guideline:
Patch test were performed to determine the irritation and allergenic potential of the test chemical
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Cetalkonium chloride
EC Number:
204-526-3
EC Name:
Cetalkonium chloride
Cas Number:
122-18-9
Molecular formula:
C25H46ClN
IUPAC Name:
cetalkonium chloride
Test material form:
solid
Details on test material:
- Name of test material: Cetalkonium chloride
- IUPAC name: CETYL DIMETHYL BENZYL AMMONIUM CHLORIDE
- Molecular formula: C25H46ClN
- Molecular weight: 396.098 g/mole
- Smiles : c1(C[N+](CCCCCCCCCCCCCCCC)(C)C)ccccc1.[ClH-]
- Inchl: 1S/C25H46N.ClH/c1-4-5-6-7-8-9-10-11-12-13-14-15-16-20-23-26(2,3)24-25-21-18-17-19-22-25;/h17-19,21-22H,4-16,20,23-24H2,1-3H3;1H/q+1;/p-1
- Substance type: Organic
- Physical state: Solid (white)
- Purity: 99.7%
Specific details on test material used for the study:
- Name of test material (as cited in study report): Cetalkonium chloride
- Molecular formula : C25H46ClN
- Molecular weight : 396.098 g/mole
- Substance type: Organic
- Physical state: solid

Test animals

Species:
other: humans
Strain:
not specified
Details on test animals or test system and environmental conditions:
- Sex: Male
- Source: Department of Dermatology, Free University Academic Hospital, Netherlands
- Age at study initiation: 28-year-old

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact skin
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
0.1%
Duration of treatment / exposure:
72 hours
Observation period:
48 and 72 hours
Number of animals:
1
Details on study design:
No data available

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Signs of irritation observed

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
0.1% aqueous test chemical was irritating to human skin.
Executive summary:

This study reports of case of allergic dermal reactions observed in humans after exposure to a hair conditioner.

A 28-year-old male had recurrent itchy dermatitis on the left side of the chest and adjacent area of the arm, where his wife usually rested her head when sleeping. He had noted that the eruption always developed after his wife had used a hair conditioner.

Patch tests with the European standard sense (ICDRG) and the conditioner (tested undiluted) showed a positive reaction only to the conditioner. Later its ingredients and additional quaternary ammonium salts were also tested separately.

 

0.1% aqueous test chemical was irritating to human skin.